Machine Operator - Shift 3

Responsibilities

• Equipment Operation
• Follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions
• Maximize equipment efficiency during operation, ensuring first pass quality product
• Periodically check/examine units from good and or reject areas to ensure proper equipment function
• Challenge equipment and or verification systems according to SOPs or batch record instructions
• Document all actions performed at the time of performance; assist with verifying various batch record or other equipment steps for teammates
• Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel
• Contact and work with internal resources and or vendors to maintain/improve equipment performance
• Meet equipment/line efficiency targets by proactively taking action to prevent downtime; work with upstream or downstream team members to help line flow
• Set-up, Tear down, & Changeover
• Thoroughly clean and clear machines in established target timelines between production operations
• Perform set-up and changeover activities independently for assigned machine; assist set-up and or changeovers on additional equipment when available
• Verify all set-up/changeover steps have been completed properly using set-up checklists
• Monitor setup and changeover process to ensure completion within target set/changeover time
• Aid Quality Assurance and or production clearance personnel with clearance of machine
• Machine Trouble Shooting
• Track machine faults and or downtime system data as problems occur; share information with Technician/Maintenance/Engineering support and help recommend appropriate action to correct the equipment issue
• Clear most faults and re-start equipment following shutdown with minimal direction or supervision according to SOPs or batch record instructions
• Aid in completing work orders for equipment related problems
• Provide recommendations and implement solutions to equipment/process challenges
• Utilize all available information and support groups to resolve problems in a timely manner with documentation and follow up to problems with inadequate/defect material
• Continuous Improvement, Training, and Safety
• Train peers and Relief Machine Operators for general equipment operation, setup and changeover
• Work with Finishing Training, Supervisors, Machine Operators, etc. to update/improve SOPs
• Immediately address any safety or training deficiencies discovered by you or your team mates; notify appropriate levels of management as necessary
• Equipment Qualification
• Support to equipment qualification/validation
• Develop SOPs for equipment implementation
• Work with Tech Services, Engineering, Maintenance and Production to ensure smooth transition to production use direct support to test components and equipment

Qualifications

• High School diploma or GED
• 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the usage of hand tools for set up and operation of automated equipment
• Physical / Safety Requirements
• Occasional (0-33%): Walking, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling
• Frequent (34-66%): Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
• Physical Requirements:
• Occasional (0-33%): Lifting up to 38 lbs, Carrying 30 lbs
• Frequent (34-66%): Lifting and carrying up to 32 lbs, Pushing and pulling up to 16 lbs
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
• Additional Requirements
• Education and experience: High School diploma or GED, 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Language skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.